NCT00179543

Brief Summary

The purpose of this study is to determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 19, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 18, 2006

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Determine whether the relaxation response is more effective than a health education control in reducing blood pressure in elderly adults with isolated systolic hypertension.

Secondary Outcomes (1)

  • Evaluate whether the relaxation response is more effective than a health education control to safely reduce blood pressure medications in elderly adults with isolated systolic hypertension..

Interventions

Relaxation responseBEHAVIORAL

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • currently taking at least 2 anti-hypertensive medications
  • systolic blood pressure between 140-159 mmHg
  • diastolic blood pressure less than 90 mmHg
  • read and understand English
  • access to a telephone
  • ability to attend all study visits

You may not qualify if:

  • other cardiovascular disease
  • major medical illness
  • previous experience with any RR eliciting technique
  • current use of:beta-agonist bronchodilators, systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Herbert Benson, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 1, 2001

Last Updated

September 19, 2006

Record last verified: 2006-09

Locations

US(1)